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The trial is taking place at:
A

Austin Retina Associates | Main | Austin, TX

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Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy (CONDOR)

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Novartis

Status and phase

Active, not recruiting
Phase 3

Conditions

Proliferative Diabetic Retinopathy

Treatments

Biological: Brolucizumab 6 mg
Procedure: Panretinal photocoagulation laser

Study type

Interventional

Funder types

Industry

Identifiers

NCT04278417
CRTH258D2301

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of brolucizumab compared to panretinal photocoagulation laser (PRP) in patients with proliferative diabetic retinopathy (PDR). This evaluation will provide information that brolucizumab is non-inferior to PRP with respect to the change in best corrected visual acuity at Week 54.

Enrollment

689 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Signed informed consent must be obtained prior to participation
  • Able to complete adequate fundus photographs and retinal images
  • Diagnosis of type 1 or 2 Diabetes Mellitus (DM) and HbA1c less than or equal to 12% at screening
  • DM treatment stable for at least 3 months
  • PDR diagnosis with no previous PRP treatment in the study eye

Exclusion criteria

  • Concomitant conditions or ocular disorders in the study eye at Screening or Baseline that could compromise a response to study treatment.
  • Presence of diabetic macular edema in the study eye
  • Active infection or inflammation in the study eye
  • Uncontrolled glaucoma (IOP greater than 25 mmHg)
  • Intravitreal anti-VEGF treatment within 6 months
  • Treatment with intraocular corticosteroids
  • End stage renal disease requiring dialysis or kidney transplant
  • Uncontrolled blood pressure
  • Systemic anti-VEGF therapy at any time

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

689 participants in 2 patient groups

Brolucizumab Arm
Experimental group
Description:
Intra-vitreal injection
Treatment:
Biological: Brolucizumab 6 mg
Panretinal photocoagulation laser Arm
Active Comparator group
Description:
laser
Treatment:
Procedure: Panretinal photocoagulation laser

Trial contacts and locations

120

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Data sourced from clinicaltrials.gov

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